Senior /Principal Statistical Programmer

Avance Clinical Pty Ltd.; Bengaluru; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Avance Clinical is seeking a Senior/Principal Statistical Programmer in Bengaluru for on-site/hybrid work. You will develop, validate, and maintain statistical programming outputs for clinical trials, collaborating with biostatisticians and data management teams.

Responsibilities include creating listings, tables and figures for study reports, developing primary and QC SAS programs for CDISC datasets, and ensuring regulatory compliance.

Qualifications

• Ordinary degree in the appropriate discipline or appropriate industry experience.
• Minimum 8 years’ experience in statistical programming in pharmaceutical / health research.
• Minimum 2-3 years in Oncology Therapeutics Area Programming.
• Strong CDISC knowledge and SDTM conversion experience.
• Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.

Responsibilities

• Preparation of listings, tables and figures for clinical study reports.
• Creation of primary and QC SAS programs for CDISC datasets and associated documentation.
• Assists with the preparation of statistical analysis plans (including preparation/review of listing, table and figure shells) and randomization schedules.
• Liaising with Data Management team and bioanalytical laboratories regarding data transfer.
• Management of project specific programming tasks and deliverables (including maintenance of planning documents and regular communication with internal stakeholders) to ensure project team will provide statistical programming deliverables according to project timelines.
• Maintain and coordinate CDISC standards, ensure maximum reuse of applied standards and involvement in ongoing process improvement initiatives
• Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
• Contribute to the development and improvement of Avance procedures related to statistical programming.
• Other duties as directed by Line Management or delegate.

Skills

CDISC knowledge

SDTM conversion

Oncology programming

Regulatory standards

Statistical programming in pharma

Education

Bachelor's degree in statistics/biostatistics/pharmacy

Tools

SAS

Job description

Senior /Principal Statistical Programmer

Who are we? We’reAvance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this areawith our founding roots dating back to the 1980’s. If youalreadywork in thisindustryyou’llknow that we are experts in our field.

Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly workenvironmentand a culture that values honesty and respect.We havea strong senseof team. We genuinely appreciateeach individualbut recognise the collectivewhenachieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Broad Purpose This is a full-time on-site/hybrid role for a Statistical Programmer based in Bengaluru. The Senior/Principal Statistical Programmer will be responsible for developing, validating, and maintaining statistical programming outputs including datasets, listings, tables, and graphs for clinical trials. This role involves collaborating with biostatisticians and data management teams, programming complex algorithms, writing macros, managing datasets, and ensuring compliance with regulatory requirements.

Core Responsibilities

• Preparation of listings, tables and figures for clinical study reports.
• Creation of primary and QC SAS programs for CDISC datasets and associated documentation.
• Assists with the preparation of statistical analysis plans (including preparation/review of listing, table and figure shells) and randomization schedules.
• Liaising with Data Management team and bioanalytical laboratories regarding data transfer.
• Management of project specific programming tasks and deliverables (including maintenance of planning documents and regular communication with internal stakeholders) to ensure project team will provide statistical programming deliverables according to project timelines.
• Maintain and coordinate CDISC standards, ensure maximum reuse of applied standards and involvement in ongoing process improvement initiatives
• Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
• Contribute to the development and improvement of Avance procedures related to statistical programming.
• Other duties as directed by Line Management or delegate.

Qualifications, Skills and Experience

• Ordinary degree in the appropriate discipline or appropriate industry experience.
• Minimum 8 years’ experience in statistical programming in pharmaceutical / health research.
• Minimum 2-3 years in Oncology Therapeutics Area Programming
• Strong CDISC knowledge and SDTM conversion experience
• Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards